BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITY SSIR

    MDR report key: 2812659 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02486
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 24, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S4
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEVICE UPGRADED PROCEDURE, THE PATIENT EXPERIENCED ASYSTOLE AFTER BOVIE WAS USED IN THE POCKET AND NO PACING WAS OBSERVED FROM THE PACEMAKER. THE PATIENT REQUIRED EXTERNAL PACING. THE PHYSICIAN WAS UNCERTAIN WHETHER THE PACEMAKER DEVICE WAS "NICKED" DURING THE BOVIE USE. WHEN TESTED WITH THE ANALYZER, THE DEVICE STILL DID NOT PACE. THE PACEMAKER WAS EXPLANTED AND WAS REPLACED WITH AN IMPLANTABLE CARDIAC DEFIBRILLATOR. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARITY SSIR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. 560

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 5092 IMPLANTABLE PACING LEAD